FDA Device recall Z-2065-2012
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopi…
- FDA Device
- Class I
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class I recall of OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopi… by Ge Oec Medical Systems, citing please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexvie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2065-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2006-11-20 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | US |
Product
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
Reason
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod
Identifiers
| code_info | 2791PU2 , 2792PU0 , 2793PU8 , 2795PU3 , 2797PU9 , 2799PU5 , 2800PU1 , 2801PU9 , 2802PU7 , 2803PU5 ,…2791PU2 , 2792PU0 , 2793PU8 , 2795PU3 , 2797PU9 , 2799PU5 , 2800PU1 , 2801PU9 , 2802PU7 , 2803PU5 , 2805PU0 , 2806PU8 , 2807PU7 , 2808PU4 , 2831PU6 , 2832PU4 , 2834PU0 , 2835PU7 , 2895PU1 , 2897PU7 , 2899PU3 , 2900PU9 , 2902PU5 , 2903PU3 , 2904PU1 , 2905PU8 , 2906PU6 & 4365PU3 , 2907PU4 , 3096PU5 , 3097PU3 , 3098PU1 , 3099PU9 & 3100PU5 , 3103PU9 , 3104PU7 , 3105PU4 , 3107PU0 , 3110PU4 , 3111PU2 , 3113PU8 & 3119PU5 , 3118PU7 , 3120PU3 , 3121PU1 , 3217PU7 & 5204PU3 , 3218PU5 , 3224PU3, 4380PU2 & 4387PU7 , 3226PU8 , 3228PU4 , 3232PU6 , 3233PU4 , 3363PU9 , 3364PU7 & 4386PU9 , 3365PU4 , 3367PU0 , 3368PU8 , 3369PU6 , 3370PU4 , 3371PU2 , 3377PU9 , 3378PU7 , 3379PU5 , 3380PU3 , 3503PU0 , 3504PU8 , 3505PU5 , 3506PU3 , 3511PU3 & 4856PU1 , 3512PU1 , 3513PU9 , 3514PU6 , 3515PU4 , 3516PU2 , 3518PU8 , 3519PU6 , 3520PU4 , 3521PU2 , 3522PU0 & 3523PU8 , |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2065-2012%22
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